NCT01413386TerminatedNot Applicable
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
Jong Taek, Lee5 sites in 1 country74 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 74
- Locations
- 5
- Primary Endpoint
- Accumulative Patency Rate
Study Overview
Brief Summary
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
Detailed Description
Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old
- •Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
- •Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
- •Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
- •Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)
Exclusion Criteria
- •Patient who previously had surgical biliary drainage
- •Patient who carrying bleeding disorder
- •Patient who have combined Hilar and/or intra-hepatic duct cancer
- •Patient who is improper to endoscopic treatment
Outcomes
Primary Outcomes
Accumulative Patency Rate
Time Frame: 6 months
Secondary Outcomes
- Possibility of Other Treatment after Obstruction(6 months)
- Accumulative Survival Rate(6 months)
- Stent migration rate(6 months)
Investigators
Jong Taek, Lee
Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd.
Study Sites (5)
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